Идёт набор NCT07233720
Zanubrutinib Combined With Rituximab in the Treatment for Patients With Marginal Zone Lymphoma
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Zanubrutinib, Rituximab.
- Кому может быть актуально
- Состояния в реестре: Marginal Zone Lymphoma. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Multicenter Prospective Real-world Study of Zanubrutinib Combined With Rituximab (ZR) in the First-line Treatment for Patients With Marginal Zone Lymphoma (MZL)
Обзор
This is a prospective single arm, multi-center, real-world study to observe the efficacy and safety of ZR (Zanubrutinib combined with Rituximab) in the first-line treatment for patients with marginal zone lymphoma (MZL).
Вмешательства
- Препарат Zanubrutinib
160mg twice daily continuous oral administration. - Препарат Rituximab
375mg/m2, Intravenous administration on day 1 of each 3-week cycle
Первичные конечные точки
- complete response rate [Срок оценки: every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment (each cycle is 28 days) to 18 months after last patient's enrollment]
Вторичные конечные точки (4)
- objective response rate [Срок оценки: every 6 weeks from the day of the first cycle of induction chemotherapy treatment (each cycle is 21 days) and every 8 weeks from the day of the first cycle of maintenance treatment (each cycle is 28 days) to 18 months after last patient's enrollment]
- progression-free survival [Срок оценки: from the day of the first cycle of treatment to the date of confirmed progressive disease or death, whichever occurs first after last patient's enrollment (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)]
- overall survival [Срок оценки: from date of the first cycle of treatment to the date of death from any cause (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)]
- incidence and relationship with study drugs of grade 3-4 adverse events [Срок оценки: from the date of the first cycle of treatment to 24 months after last patient's enrollment (each cycle is 21 days for induction treatment, and 28 days for maintenance treatment)]
Критерии участия
Критерии включения
- Patients with CD20-positive marginal zone lymphoma diagnosed by histopathology
- First-line treatment with the combination regimen of zanubrutinib and rituximab
- No receiving systematic treatment before enrollment
- Having at least one measurable lesions. Measurable lesions were defined as: the longest diameter of lymph node lesions in CT cross-sectional images > 1.5 cm, or the longest diameter of the extranodal lesion is greater than 1.0cm
- The patients voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Критерии исключения
- Other malignant tumor history or active malignant tumor need be treated
- In addition to zanubrutinib and rituximab, other anti-tumor drug treatments were also received simultaneously (except for glucocorticoids aimed at controlling symptoms before formal treatment).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university — Чжэнчжоу
Идентификаторы
NCT: NCT07233720 · HNSZLYYNHL10